Neuroprosthetic System for Spinal Cord Injury (NNP-UE+T Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kevin Kilgore
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This study is to evaluate the use of a fully implanted device for providing hand function, reach, and trunk function to individuals with cervical spinal cord injury.
Funding Sources:
FDA OOPD NIH NINDS
How is the Networked Neuroprosthetic System treatment different from other treatments for spinal cord injury?
The Networked Neuroprosthetic System (NNP) is unique because it is a fully implanted modular system that can restore multiple functions by electrically activating paralyzed muscles in coordinated patterns. Unlike traditional single-device neuroprostheses, the NNP uses a networked approach with multiple modules for power, signal processing, and stimulation, allowing for more complex and customizable control of muscle movements.
13567Is the Networked Neuroprosthetic System safe for humans?
The Networked Neuroprosthetic System has been tested in people with spinal cord injuries and has shown to be safe, with no medical complications reported from the implanted components. The system has been used for over 20 years in some cases, demonstrating its durability and safety.
12478What data supports the effectiveness of the treatment Networked Neuroprosthetic System for Grasp and Trunk in individuals with spinal cord injury?
Research shows that the Networked Neuroprosthesis (NNP) system is functional and capable of generating stimulus pulses and recording signals, and an advanced neuroprosthesis has been shown to improve grasp strength, range of motion, and independence in daily activities for individuals with cervical level spinal cord injury, with no medical complications reported.
12567Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like severe cardiopulmonary disease or are on medications that interact with implantable devices, you might need to discuss this with the trial team.
Eligibility Criteria
This trial is for individuals over 16 years old with cervical spinal cord injuries (C4-C8 level, AIS grade A-D) who are at least six months post-injury. Participants must have some arm and trunk muscle strength, be medically stable for surgery, and willing to participate. Pregnant women, those with certain neurological conditions or severe diseases, active infections, or other implantable devices are excluded.Inclusion Criteria
I am older than 16 years.
I have a spinal cord injury at the neck level and it's been over 6 months since the injury.
My arm and trunk muscles respond well to stimulation.
I can move my arm and some upper body muscles with some strength.
I can move my arm against gravity.
I am medically cleared for surgery.
Exclusion Criteria
I have fractures that stop me from using my arm or body properly.
I currently have an untreated infection like a skin ulcer, UTI, or pneumonia.
I have a neurological condition like multiple sclerosis or diabetes affecting my nerves.
I do not have severe heart, lung, blood clotting disorders, HIV, or severe slow heart rate.
I have significant nerve damage in my upper limbs.
My spinal cord injury is getting worse and I am getting implants on both sides.
Participant Groups
The study tests a fully implanted neuroprosthetic system designed to restore hand function, reach ability, and trunk control in people with cervical spinal cord injuries. It aims to evaluate the device's effectiveness in improving motor functions that were affected by the injury.
1Treatment groups
Experimental Treatment
Group I: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention
Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.
Networked Neuroprosthetic System for Grasp and Trunk is already approved in United States for the following indications:
🇺🇸 Approved in United States as Networked Neuroprosthetic System for:
- Cervical spinal cord injury for hand function, reach, and trunk function
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
MetroHealth Medical CenterCleveland, OH
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Who is running the clinical trial?
Kevin KilgoreLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Congressionally Directed Medical Research ProgramsCollaborator
Case Western Reserve UniversityCollaborator
FDA Orphan Products DivisionCollaborator
References
An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. [2019]An advanced neuroprosthesis that provides control of grasp-release, forearm pronation, and elbow extension to persons with cervical level spinal cord injury is described. The neuroprosthesis includes implanted and external components. The implanted components are a 10-channel stimulator-telemeter, leads and electrodes, and a joint angle transducer; the external components are a control unit and transmitter-receiver coil. The system has completed preclinical testing and has been implanted fully in 3 persons and partially in 1 person, all with tetraplegia caused by spinal cord injury at C5 and C6. The minimum follow-up time for any system component is 16 months. All subjects had improvements in grasp strength, range of motion, and ability to grasp objects and increased independence in activities of daily living. Each subject became a regular user of the neuroprosthesis and is satisfied with it. The implanted components have not caused any medical complications. The operation of the electrodes and sensors has been stable. The data show that this advanced neuroprosthetic system is safe and can provide grasping and reaching ability to individuals with cervical level spinal cord injury.
Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. [2019]To test the efficacy and safety of the NESS Handmaster neuroprosthesis with subjects with C5 or C6 tetraplegia.
Neuroprosthetics of the upper extremity--clinical application in spinal cord injury and future perspectives. [2005]Within the last couple of years, partial restoration of lost motor functions in a larger number of spinal cord injured patients has become possible by the introduction of neuroprostheses into the clinical environment. The Freehand system in particular is the first implantable neuroprosthesis from which a certain group of tetraplegic patients with stable shoulder function, but missing or weak grasp and hold function of the hand do benefit. The system is based on the combination of electrical stimulation and operative tendon transfers and thus represents a multicomponent concept for long-term restoration of the grasp function. The crucial prerequisites for successful use of an implantable neuroprosthesis are the right indication, careful preoperative muscle stimulation, differentiated planning of the surgery and functional training adopted to the individual residual functions. After successful completion of an extensive rehabilitation program, patients are able to use the system for activities of daily living without the need for special additional aids, which enhances their quality of life and independency. In order to extend the group of potential users of neuroprostheses in the future, new technological developments will have to take into account that nowadays the majority of spinal cord injured patients suffer from an incomplete lesion of the spinal cord. For these particular patients who still possess residual functions, modular, "naturally" controllable systems for supporting these functions are needed rather than complex systems to substitute them.
Twenty year experience with implanted neuroprostheses. [2020]The long-term durability and safety of implanted devices is of great importance in the field of motor neuroprosthetics, where systems may possibly be utilized in excess of 50 years by some individuals. Neuroprosthetic systems have now been implanted in the upper extremity of spinal cord injured individuals for more than 20 years. The experience with these systems shows a high level of durability of the implanted components, particularly the stimulating electrodes and leads.
A novel command signal for motor neuroprosthetic control. [2021]Neuroprostheses can restore functions such as hand grasp or standing to individuals with spinal cord injury (SCI) using electrical stimulation to elicit movements in paralyzed muscles. Implanted neuroprostheses currently use electromyographic (EMG) activity from muscles above the lesion that remain under volitional control as a command input. Systems in development use a networked approach and will allow for restoration of multiple functions but will require additional command signals to control the system, especially in individuals with high-level tetraplegia.
Implanted neuroprosthesis for restoring arm and hand function in people with high level tetraplegia. [2021]To develop and apply an implanted neuroprosthesis to restore arm and hand function to individuals with high level tetraplegia.
Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. [2022]Implantable motor neuroprostheses can restore functionality to individuals with neurological disabilities by electrically activating paralyzed muscles in coordinated patterns. The typical design of neuroprosthetic systems relies on a single multi-use device, but this limits the number of stimulus and sensor channels that can be practically implemented. To address this limitation, a modular neuroprosthesis, the "Networked Neuroprosthesis" (NNP), was developed. The NNP system is the first fully implanted modular neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording, and stimulating components. This paper describes the design of stimulation and recording modules, bench testing to verify stimulus outputs and appropriate filtering and recording, and validation that the components function properly while implemented in persons with spinal cord injury. The results of system testing demonstrated that the NNP was functional and capable of generating stimulus pulses and recording myoelectric, temperature, and accelerometer signals. Based on the successful design, manufacturing, and testing of the NNP System, multiple clinical applications are anticipated.
Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. [2023]Based on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls.